MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A); LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Headache (1880); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On (b)(6) 2017 a patient (pt) called our affiliate in (b)(4) to report he/she purchased the 1-day acuvue trueye brand contact lenses and experienced pain (affected eye unknown) when inserting the suspect lens in (b)(6) 2017.The pt reports he/she usually wears the acuvue oasys brand lenses.On (b)(6) 2017 the pt went to a hospital and was diagnosed with corneal staining which produced an ¿infection¿.¿something like white swelling on the eye was detected¿.The pt reported ¿if it gets worse, the pt might be hospitalized¿.The pt reported the symptoms had resolved.On (b)(6) 2017 a call was placed to the pt and additional information was provided: the affected eye was the od; on (b)(6) 2017 the pt went to the eye clinic he/she visits quarterly for examinations; the pt was advised to visit another eye clinic at once since the eye condition was not good.At that visit, pt was prescribed bestron for ophthalmic 0.5%, gatifloxacin ophthalmic solution 0.3%, tobracin ophthalmic solution 0.3% and tarivid eye ointment 0.3%.Contact lens wear was discontinued.The pt was instructed to see an ophthalmologist at the hospital on (b)(6) 2017.The pt reported the diagnosis was the same ¿staining in eyeball which produced infection¿.Contact lens wear was discontinued.Culture result showed only the od was infected.The pt reported he/she was advised to use the prescribed eye drops six times daily.The pt reported the eye got better in a week and the swelling resolved.Pt reported headache and ¿feeling physically tired¿.The pt reported he/she returned to the clinic on (b)(6) 2017 and was advised to return in a week.In (b)(6) 2017 the pt went to the eye clinic twice for consultation.The pt reported he/she is currently using flumetholon ophthalmic suspension every morning and night and was unable to check to see when it was prescribed.Pt reported ¿something like swelling is slightly remaining at the moment¿.The pt wears a competitive contact lens for ¿a short time¿.The pt refused the medical interview with the treating ecp.No additional medical information was received and no additional medical information is expected.The suspect product was discarded.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 5253480109 was produced under normal conditions.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological parkway; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7043044
• MDR Text Key: 92473297
• Report Number: 9617710-2017-05059
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5253480109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention